Summary Of Registration and Listing Requirements

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SUMMARY OF REGISTRATION AND LISTING REQUIREMENTS FOR THE MANUFACTURE OR DISTRIBUTION OF HUMAN PHARMACEUTICALS
TYPE OF FIRM
REGISTRATION STATUS
LISTING STATUS
Manufacturer including homeopathic & controlled drugs]
yes
yes
Contract Manufacturer
yes
yes
Own/Private Label Distributor
no
yes
Wholesale Distributor
no
no
Own Label Repacker
yes
yes
Own Label Relabeler [including recirculizer]
yes
yes
Contract Relabeler
yes
no
Contract Testing Laboratory [dosage forms & active ingredient release]
yes
no
Contract Testing Lab [doing non-release tests]
no
no
Contract Sub-Manufacturer
yes
no
IND Manufacturer [Clinical Drugs]
no
no
NDA and ANDA Manufacturer
yes
yes
Sponsor/Monitors/Clinical Investigator
no
no
Contract Sterilizer
yes
no
Fulfillment Packager [adding substantive labeling]
yes
no
Mail Order House [adding insubstantial labeling]
no
no
Printing House
no
no
Medical Gas Transfiller
yes
yes
First Aid/Rescue Squad [transfilling for own use]
no
no
Medical Gas Transfiller [operating out of a van]
yes
yes
Contract Assembler
yes
no
Active Drug Substance Manufacturer
yes
yes
Excipient Drug Manufacturer
no
no
Manufacturer of Research Drugs
no
no
Drug Importer
no
no
Foreign Drug Manufacturer
yes
yes
Methadone Clinic
no
no
Retail Pharmacy
no
no
Manufacturing Pharmacy
yes
yes
Regional Admixture Pharmacy
yes
no
Source:
http://www.fda.gov/cder/drls/default.htm